Pharmacy Technician Review. Pharmacy Technician Review. Program Disclosure. Program Disclosure. Parenteral Routes of Administration
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1 Pharmacy Technician Review Aseptic Technique: Presented by: Presented by: Pamela Grimm, CPhT Pharmacy Pamela Grimm, Technician CPhT Manager University Pharmacy of Technician Iowa Hospitals and Clinics Iowa Manager City, IA University of Iowa Program Disclosure This program was recorded live as part of the Collaborative Education Institute s Technician Review in October CEI and its staff take full responsibility for the program planning. This presentation is owned solely by CEI. Requests for permission to utilize any part of this presentation should be directed to Jennifer Moulton, jmoulton@iarx.org. Pamela Grimm indicated that she had no actual or potential conflicts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation. The program is delivered in this online format by the Collaborative Education Institute (CEI). This program was originally presented and recorded live as part of the Pharmacy Technician Review, October 16-17, 2008, in Des Moines, Iowa and sponsored by The Collaborative Education Institute The Collaborative Education Institute Pharmacy Technician Review Aseptic Technique: Presented by: Pamela Grimm, CPhT Pharmacy Technician Manager University of Iowa Hospitals and Clinics Iowa City, IA Program Disclosure This program was recorded live as part of the Collaborative Education Institute s Technician Review in October CEI and its staff take full responsibility for the program planning. This presentation is owned solely by CEI. Requests for permission to utilize any part of this presentation should be directed to Jennifer Moulton, jmoulton@iarx.org. Pamela Grimm indicated that she had no actual or potential conflicts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation. The program is delivered in this online format by the Collaborative Education Institute (CEI). This program was originally presented and recorded live as part of the Pharmacy Technician Review, October 16-17, 2008, in Des Moines, Iowa and sponsored by The Collaborative Education Institute The Collaborative Education Institute Today Parenteral Routes of Administration Parenteral routes only Intravenous (IV) - Vein Intramuscular (IM) - Muscle Subcutaneous (SC or SQ) - Beneath the skin Intradermal (ID) - Top layer of the skin Intra-arterial - Artery Intrathecal (IT) - Spinal canal Intraarticular - Joint Many others - Intraperitoneal, intrapleural, etc Parenteral Routes of Administration Advantage Quick onset Amount of drug administered = amount of drug available in the body Does not undergo first-pass metabolism by the intestine and the liver Also can produce local effect when given locally 1
2 Parenteral Routes of Administration Disadvantage Once administered, it s hard to stop the effect More chance of overdose in case of mistakes Local reactions at injection sites Pyrogens Risk of infection at injection sites and blood Must use aseptic technique Human touch is the most common source of contamination Sterilization Sterile? Absence of all living microorganisms Does not mean absence of pyrogens or viruses Filtration Sterilization The most common method of sterilization in a pharmacy A filter must have a pore size less than 0.3 microns Method of sterilization Cold sterilization by chemicals Ethylene oxide gas Radiation Ultrasonic Heat sterilization by steam and pressure In an autoclave In a hot air oven Pyrogen Any substance that can cause a fever Can be a bacterial endotoxin or an exotoxin An endotoxins is a large molecule that consists of sugar chains and a lipid Endotoxins are usually the cause of the pyrogenic activity it of a contaminated drug Does not get filtered by a 0.2 micron filter Not destroyed by an autoclave Contaminated products must be discarded Aseptic Technique Handling without contamination Should be used for compounding sterile products Anyone preparing sterile products should undergo aseptic technique training by experienced personnel Aseptic technique training should include: Instructional video Professional publications Hands on aseptic technique manipulation training Should include media-fill testing 2
3 Avoid contamination of the air No jewelry No makeup No Artificial nails No fingernail polish Scrub properly Scrub nails, fingers, hands, wrists, and forearms for at least 30 seconds. Use a low lint towel to dry hands or use a hand dryer Wear a hair cap, a knee-length gown, gloves, and shoe covers (important to gown from your head downwards) Categorized by the air quality ISO Class 5 Area For sterile product preparation No more than 3520 particles, 0.5 microns or larger, per cubic meters of air Equivalent to the Class 100 area, which has a count of no more than 100 particle, 0.5 microns and larger per cubic foot of air Categorized by the air quality ISO Class 6, 7, 8 Areas For non-sterile product preparation Respectively 1000, 10000, and particles per cubic foot of air Buffer area The compartment in which the laminar flow workbench is located Separate from other pharmacy operations The second cleanest space in a pharmacy Must maintain a positive air pressure No cardboard box should enter this area Anteroom Highly clean A separate compartment between the buffer area and other pharmacy operation Keep hand-wash equipments and other supplies such as gowns, gloves, and hair caps. Positive pressure - Less pressure than the buffer area The dirty side and the clean side are separated by a line Open packages in this area Surfaces of the preparation areas Smooth Non-shedding Easily cleaned/disinfected No seams and cracks 3
4 Critical Site Opening or surface of any sterile product that can come in contact with the product in preparation i e. Needle cap, the tip of the syringe, open neck of an ampoule, the top of the vial closure Laminar Flow Air in a confined area moving with uniform speed along parallel lines Laminar flow workstations can filter out all particles that are 0.3 microns or larger in diameter Horizontal Flow Outward air flow towards the operator Vertical flow Downward air flow toward the bench Know that the LFW only keeps sterile products sterile It does not remove contamination already present on the items placed inside the workstation Cleaning the LFW General rule Use non-shedding wipes and 70% isopropyl alcohol Do not spray the sanitizing agent directly on the hood Start at the end closest to the filter Move outward from the top edge of the side to the bottom Wipe from side to side Wipe from the filter to the outside Wipe from the cleanest part outward 4
5 Working in the LFW Wipe down any products not in a sealed package with 70% alcohol Remove the protective packaging right at the edge of the hood Keep a syringe in a protective wrap until right before its use. It should be placed 6 inches inside the edge All work must be done 6 inches inside the hood Nothing should block the airflow to another object in the hood Do not block the airflow with your hands or body Working in the LFW Minimize movement while working in the hood All materials should be kept 6 inches inside the hood The items to be discarded should be placed no more than 6 inches into the hood Needles and other sharp objects must be discarded into a designated container Syringes Plastic or glass Plastic is used most often Examine the package carefully for any signs of puncture or contamination The ribs of the plunger and the tip of the syringe are the critical sites Use the smallest syringes possible For example, use a 5 ml syringe instead of 10 ml to transfer 4 ml of drug Remove the package inside the hood Needle sizes The larger the gauge, the thinner the needle Use 18G for a large volume transfer Use 21G for a small volume transfer The needle length are specified by inches The needle tip and the hub located above the needle are critical sites Putting the needle on a syringe Examine the package carefully for any signs of puncture or contamination Remove the packaging inside the hood Do not tear the paper packaging when removing a needle or a syringe May generate paper particles Do not touch the needle and keep the paper wrap on the syringe - Grab the needle over the paper wrap Hold the needle with the thumb and first finger of your nondominant hand and the syringe with your dominant hand Assemble them together by twisting the needle Remember not to block the airflow to the needle with the syringe in your hand or vice versa Drawing up the right volume With the needle cap on, push the plunger all the way down to unlock the syringe Pull back the syringe up to the volume you are about to draw up and inject the air into the vial to equalize pressure Draw up the drug to the desired volume Tap the syringe to remove air before removing the syringe from the vial Readjust the volume as necessary Right here NOT here 1 2 5
6 Ampoules Wipe the ampoule with a 70%-alcohol swab and let it dry Use caution when opening the ampoule Use only enough amount of force Break the ampoule away from you toward the side of the hood Never break it toward the HEPA filter Use an ampoule opener if you experience difficulties Do not push air into an ampoule Use a filter when you draw up the drug You must cannot use one filter needle to draw up and to inject - It should be used only in one direction Vials Flick the top off Wipe the top of the vial with a 70% alcohol swab and let it dry A single-dose vial cannot be entered more than once Once out of the hood, it must be discarded Amultidose multi-dose vial can be entered multiple times Multi-dose vials contain preservatives Multi-dose vials exp 28 days after the vial has been punctured Insert the needle at an angle of degrees with the bevel of the needle up Once penetrated, hold the needle in a vertical position Remember not to block the airflow to the syringe and to the vial Reconstitution of a powder Some drugs cannot stay stable in a solution form so they are available in a powder form They need to be reconstituted with a diluent before use Diluent A fluid solvent used to dissolve the powder Most drugs specify how much diluent to mix with Reconstitution of a powder Note that powders also take up a certain amount of volume Withdraw the pre-specified amount of the correct diluent using aseptic technique Inject the diluent into the vial of powder Let the air re-enter the syringe to equalize pressure Shake the vial well until all powder is dissolved Hold the vial in the light for visual inspection of particles Use filtering if instructed to do so or when a particle exists in the vial after a vigorous shaking Double-check your work Is everything correct? Label Complete and error-free? Correct drug and strength of the drug Correct additive and strength of the additive Correct quantity Visual inspection Make sure no precipitation has occurred Make sure the admixture is clear and free of particulate matters May use a black sheet of paper to identify a particle Chemotherapeutic Agents Handling these agents may pose an occupational hazard Anyone who is pregnant, nursing or trying to become pregnant should not prepare chemotherapy. Minimize unnecessary exposure Must receive special training All chemo agents should be prepared in a biological safety cabinet designated for preparing cytotoxic drugs 6
7 Chemotherapeutic Agents In order to avoid exposure to chemo agents: Wear protective clothing Place an absorbent drape on the work surface Must be after spillage Lower the window as low as possible Use negative pressure technique or a closed system device such as PhaSeal when using chemo agents Be sure to vent the vial to avoid positive pressure Discard anything that may potentially have come in contact with into a hazardous material waste container Review The pore size of a sterilizing filter is: A. 0.1 microns B. 0.2 microns C. 0.5 microns D microns E microns Questions? Thank you! 7
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